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HEMGENIX®-logo-bg HEMGENIX® (etranacogene dezaparvovec)


HEMGENIX is administered as a one-time-only intravenous infusion— delivered in 1-2 hours in an outpatient setting. No special pretreatment of patients is required.

  • HEMGENIX should only be prepared and administered by trained staff at an administration center


Interested in becoming an administration center? Contact your local CSL Behring representative, call HEMGENIX Connect℠ at 1-833-436-0021, Monday through Friday from 8AM–8PM ET or complete the form here

  • Each dosing kit is personalized to your patient’s weight

  • HEMGENIX is delivered as a single dose of 2 mL/kg body weight*

  • HEMGENIX does not contain preservatives. Use aseptic technique and proper engineering controls (eg, a biological safety cabinet or isolator) according to institutional policies during the preparation and administration of HEMGENIX

*Further dilution with 0.9% normal saline is required.

Questions along the way? Call HEMGENIX Connect℠ at 1-833-436-0021, Monday through Friday from 8 AM-8 PM ET.

Questions along the way? Call HEMGENIX Connect℠ at 1-833-436-0021, Monday through Friday from 8 AM-8 PM ET.

Man standing with hands in pockets Patient portrayal

Product preparation and administration instructions are available as a step-by-step video


Administer HEMGENIX as a single-dose intravenous infusion through a peripheral venous catheter:

1 IV bag with magnifying glass icon

Visually inspect

Visually inspect diluted HEMGENIX solution prior to administration. The diluted HEMGENIX should be clear and colorless.

  • DO NOT use if particulates, cloudiness, or discoloration are visible; call CSL Behring at
    1-833-436-0021 immediately.
  • Use the diluted HEMGENIX within 24 hours after the dose preparation.
2 IV bag with filter icon

Use an integrated filter

Use an integrated (in-line) 0.2-mcm filter made out of polyether sulfone (PES).

3 IV bag filter icon

Prepare the line

Connect the prefilled IV infusion line/drip chamber to the main intravenous line, which has been primed with sterile 0.9% normal saline solution prior to use.

4 Neddle with cross through circle icon

Infuse at a constant rate

Infuse the diluted HEMGENIX solution at a constant infusion rate of 500 mL/hour (8 mL/min).

  • DO NOT administer HEMGENIX as an intravenous push or bolus.
  • DO NOT infuse the diluted HEMGENIX solution in the same intravenous line with any other products.
  • DO NOT use a central line or port.

In the event of an infusion reaction* during administration:

The rate of infusion may be reduced or stopped to manage the infusion reaction. If the infusion is stopped, restart at a slower rate when the infusion reaction is resolved.

If the infusion rate needs to be reduced, or stopped and restarted, HEMGENIX should be infused within 24 hours after dose preparation.

* Symptoms may include chest tightness, headaches, abdominal pain, lightheadedness, flu-like symptoms, shivering, flushing, rash, and hypertension.

4 Circle with check icon

Ensure all HEMGENIX is delivered

After the entire content of the bag(s) is infused, flush the infusion line and the infusion tubing at the same infusion rate (8 mL/min) with 0.9% normal saline solution to ensure all HEMGENIX is delivered.

  • Treat spills of HEMGENIX with a virucidal agent with proven activity against non-enveloped viruses.
  • Dispose of unused product and disposable materials that may have come in contact with HEMGENIX in accordance with local biosafety guidelines applicable for the handling and disposal of pharmaceutical waste.

Closely monitor patients for infusion reactions throughout the infusion period and for at least 3 hours after the end of the infusion.

Learn more about HEMGENIX in a video series featuring leading experts.

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Warning and Precautions

Infusion Reactions

Infusion reactions, including hypersensitivity reactions and anaphylaxis, may occur. Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. Re-start administration at a slower infusion once resolved.

Hepatotoxicity/Hepatocellular Carcinoma

Post-dose, monitor for elevated transaminase levels. Consider corticosteroid treatment should elevations occur. The integration of liver-targeting AAV vector DNA into the genome may carry the theoretical risk of hepatocellular carcinoma development. For patients with preexisting risk factors for hepatocellular carcinogenicity, perform regular (eg, annual) abdominal ultrasound and alpha-fetoprotein testing following administration.

Immune-mediated neutralization of the AAV5 vector capsid

Preexisting neutralizing anti-AAV antibodies may impede transgene expression at desired levels.

Monitoring Laboratory Tests

In addition to monitoring liver function, monitor for Factor IX activity and Factor IX inhibitors after administration.

Adverse Reactions

The most common adverse reactions (incidence ≥5%) were elevated ALT, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, nausea, malaise, and elevated AST.


HEMGENIX®, etranacogene dezaparvovec-drlb, is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:

  • Currently use Factor IX prophylaxis therapy, or
  • Have current or historical life-threatening hemorrhage, or
  • Have repeated, serious spontaneous bleeding episodes.

HEMGENIX is for single use intravenous infusion only.

Contraindications: None.

Please see full prescribing information for HEMGENIX.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or